Dermavant Sciences has submitted a Supplemental New Drug Application (sNDA) to the U.S. FDA for Vtama® (tapinarof) cream, 1% for the topical treatment of atopic dermatitis (AD) in adults and children 2 years of age and older. VTAMA cream, 1% is currently FDA-approved for the topical treatment of plaque psoriasis in adults.
The sNDA submission is supported by positive Phase 3 data from ADORING 1 and ADORING 2, two identical, double-blind, randomized, vehicle-controlled, pivotal trials, as well as data from an interim analysis of ADORING 3, a Phase 3, 48-week, open-label, long-term extension study. In the pivotal trials, Vtama cream demonstrated highly statistically significant improvement compared to in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) scores of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline at Week 8, the primary endpoint. Vtama cream also demonstrated highly statistically significant improvement in the proportion of patients with ≥75% improvement in the Eczema Area and Severity Index (EASI75) from baseline to Week 8 compared to patients on vehicle, a key secondary endpoint in the pivotal trials. Patients 12 years of age and older, the population in whom the PP-NRS is validated, who received Vtama cream also experienced a statistically significant improvement in itch as assessed by a ≥4-point improvement in the patient reported Peak Pruritus Numeric Rating Scale (PP-NRS) score compared to patients on vehicle (P=0.0366 for ADORING 1 and P=0.0015 for ADORING 2), another key secondary endpoint.
There were no new safety or tolerability signals of concern in the study cohorts, including children 2 years of age and older. Adverse events were mostly mild to moderate with a low study discontinuation rate due to adverse events.
Vtama cream is a novel, aryl hydrocarbon receptor agonist in development as a once-daily, cosmetically elegant, and steroid-free, topical cream. In 2022 it became the first non-steroidal topical novel chemical entity launched for psoriasis in the U.S. in more than 25 years.
The post Dermavant Submits sNDA for VTAMA for Topical Treatment of AD in Adults and Children appeared first on Dermatology Education Foundation.